Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 4, 2013
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture a…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
DePuy Orthopaedics, Inc. recalled SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Kn… - a moderate-severity action.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Kn… was recalled by DePuy Orthopaedics, Inc. in December 4, 2013. Reason: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument…. Check the official notice for the remedy. Verify recall #Z-0421-2014 with the FDA Devices before acting.
The recall
DePuy Orthopaedics, Inc. issued this moderate-severity FDA Devices recall-DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument….
- Moderate
- severity level
- 29K units
- affected scope
- Class II
- classification
- December 4, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0421-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0421-2014) was formally reported on December 4, 2013, with the manufacturer initiating the action on November 18, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. DePuy Orthopaedics, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 29,235 units in total / 2008 through November 2013.
The documented reason for this recall is: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMAR…. 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
29,235 units in total / 2008 through November 2013
Related Recalls
6
3 from same agency
Product description
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Reason for recall
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0421-2014 |
| Date reported | December 4, 2013 |
| Date initiated | November 18, 2013 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 29,235 units in total / 2008 through November 2013 |
| Distribution | Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMA… |
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-0421-2014) 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? ▼
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 29,235 units in total / 2008 through November 2013.
Why was this product recalled? ▼
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2013. Severity: Moderate. Recall number: Z-0421-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0421-2014) 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 December 4, 2013. 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.