PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported May 25, 2016

Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Recall #
Z-1677-2016
Affected scope
3955
Initiated
May 4, 2016
Compiled from official public sources by the publisher.
Verify with FDA Devices →
View my saved recalls

Zimmer Manufacturing B.v. recalled Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47… - a moderate-severity action.

Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47… was recalled by Zimmer Manufacturing B.v. in May 25, 2016. Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.. Check the official notice for the remedy. Verify recall #Z-1677-2016 with the FDA Devices before acting.

The recall

Zimmer Manufacturing B.v. issued this moderate-severity FDA Devices recall-A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws..

Moderate
severity level
4K units
affected scope
Class II
classification
May 25, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1677-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502

Reason for recall

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1677-2016
Date reported May 25, 2016
Date initiated May 4, 2016
Recalling firm Zimmer Manufacturing B.v.
Firm location Mercedita, PR
Affected scope 3955
Distribution Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

3955 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1677-2016) 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? ▼
Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502. Recalled by Zimmer Manufacturing B.v.. Units affected: 3955.
Why was this product recalled? ▼
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2016. Severity: Moderate. Recall number: Z-1677-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada..
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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

TJX Recalls Foldable Lounge Chairs Due to… 2016-05-25 Noble House Recalls Counter Stools Due to… 2016-05-25 Honda Recalls Mini Tillers Due to Risk of… 2016-05-25 Hed Cycling Recalls Bicycle Rims Due to C… 2016-05-25

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

NeuroBlate System SideFire Select 2.2 mm… 2016-05-25 ANSPACH, Rx only, Otologic Curved Micro (… 2016-05-25 ANSPACH, Rx only, Otologic Curved Micro (… 2016-05-25 Lumenis M22 System Model Number: GA-00054… 2016-05-25

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported May 25, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026