Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 23, 2016
Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7 118101025 FREE-LOCK LAG SCREW, 12.7 118101027 FREE-LOCK LAG SCREW, 12.7 118101030 FREE-LOCK LAG SCREW, 12.7 118101032 FREE-LOCK LAG SCREW, 12.7 118101035 FREE-LOCK LAG SCREW, 12.7 118101037 FREE-LOCK LAG SCREW, 12.7 11810
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Manufacturing B.v. recalled Product 30 consists of all product under product code: KTT and same usage: Item no: 1… - a moderate-severity action.
Product 30 consists of all product under product code: KTT and same usage: Item no: 1… was recalled by Zimmer Manufacturing B.v. in March 23, 2016. Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Au…. Check the official notice for the remedy. Verify recall #Z-1128-2016 with the FDA Devices before acting.
The recall
Zimmer Manufacturing B.v. issued this moderate-severity FDA Devices recall-As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Au….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- March 23, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1128-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1128-2016) was formally reported on March 23, 2016, with the manufacturer initiating the action on January 11, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Manufacturing B.v. is listed as the recalling firm, operating out of Mercedita, PR. Federal records list the affected scope as 3500.
The documented reason for this recall is: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3500
Related Recalls
6
3 from same agency
Product description
Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7 118101025 FREE-LOCK LAG SCREW, 12.7 118101027 FREE-LOCK LAG SCREW, 12.7 118101030 FREE-LOCK LAG SCREW, 12.7 118101032 FREE-LOCK LAG SCREW, 12.7 118101035 FREE-LOCK LAG SCREW, 12.7 118101037 FREE-LOCK LAG SCREW, 12.7 118101040 FREE-LOCK LAG SCREW, 12.7 118101042 FREE-LOCK LAG SCREW, 12.7 118101045 FREE-LOCK LAG SCREW, 12.7 118101047 FREE-LOCK LAG SCREW, 12.7 118101052 FREE-LOCK LAG SCREW, 12.7 118101055 FREE-LOCK LAG SCREW, 12.7 118101057 FREE-LOCK LAG SCREW, 12.7 118101522 FREE-LOCK LAG SCREW, 15.8 118101525 FREE-LOCK LAG SCREW, 15.8 118101527 FREE-LOCK LAG SCREW, 15.8 118101530 FREE-LOCK LAG SCREW, 15.8 118101532 FREE-LOCK LAG SCREW, 15.8 118101547 FREE-LOCK LAG SCREW, 15.8 118109010 FREE-LOCK SUPRACOND TUBE/ 118109510 FREE-LOCK SUPRACOND TUBE/ 118113005 FREE-LOCK TUBE & SCP PLAT 118113006 FREE-LOCK TUBE & SCP PLAT 118113010 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113510 FREE-LOCK TUBE & SCP PLAT 118113594 FREE-LOCK TUBE & SCP PLAT 118114005 FREE-LOCK TUBE & SCP PLAT 118114006 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114004 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114504 FREE-LOCK TUBE & SCP PLAT 118114505 FREE-LOCK TUBE & SCP PLAT 118114506 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118115004 FREE-LOCK TUBE & SCP PLAT 118115005 FREE-LOCK TUBE & SCP PLAT 118115006 FREE-LOCK TUBE & SCP PLAT 118115008 FREE-LOCK TUBE & SCP PLAT 118115094 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113004 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Reason for recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1128-2016 |
| Date reported | March 23, 2016 |
| Date initiated | January 11, 2016 |
| Recalling firm | Zimmer Manufacturing B.v. |
| Firm location | Mercedita, PR |
| Affected scope | 3500 |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1128-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7 118101025 FREE-LOCK LAG SCREW, 12.7 118101027 FREE-LOCK LAG SCREW, 12.7 118101030 FREE-LOCK LAG SCREW, 12.7 118101032 FREE-LOCK LAG SCREW, 12.7 118101035 FREE-LOCK LAG SCREW, 12.7 118101037 FREE-LOCK LAG SCREW, 12.7 118101040 FREE-LOCK LAG SCREW, 12.7 118101042 FREE-LOCK LAG SCREW, 12.7 118101045 FREE-LOCK LAG SCREW, 12.7 118101047 FREE-LOCK LAG SCREW, 12.7 118101052 FREE-LOCK LAG SCREW, 12.7 118101055 FREE-LOCK LAG SCREW, 12.7 118101057 FREE-LOCK LAG SCREW, 12.7 118101522 FREE-LOCK LAG SCREW, 15.8 118101525 FREE-LOCK LAG SCREW, 15.8 118101527 FREE-LOCK LAG SCREW, 15.8 118101530 FREE-LOCK LAG SCREW, 15.8 118101532 FREE-LOCK LAG SCREW, 15.8 118101547 FREE-LOCK LAG SCREW, 15.8 118109010 FREE-LOCK SUPRACOND TUBE/ 118109510 FREE-LOCK SUPRACOND TUBE/ 118113005 FREE-LOCK TUBE & SCP PLAT 118113006 FREE-LOCK TUBE & SCP PLAT 118113010 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113510 FREE-LOCK TUBE & SCP PLAT 118113594 FREE-LOCK TUBE & SCP PLAT 118114005 FREE-LOCK TUBE & SCP PLAT 118114006 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114004 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114504 FREE-LOCK TUBE & SCP PLAT 118114505 FREE-LOCK TUBE & SCP PLAT 118114506 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118115004 FREE-LOCK TUBE & SCP PLAT 118115005 FREE-LOCK TUBE & SCP PLAT 118115006 FREE-LOCK TUBE & SCP PLAT 118115008 FREE-LOCK TUBE & SCP PLAT 118115094 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113004 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.. Recalled by Zimmer Manufacturing B.v.. Units affected: 3500.
Why was this product recalled? ▼
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2016. Severity: Moderate. Recall number: Z-1128-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1128-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 23, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.