CLASS II Device recall · Reported 15 Oct 2014 · FDA Enforcement Report
Charnley PN Retract & Handle recalled by DePuy Orthopaedics
DePuy Orthopaedics is recalling Charnley PN Retract & Handle, distributed nationwide in the US. The recall was initiated on 27 Aug 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0061-2015
- FDA event ID
- 69052
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2014
- FDA classified
- 9 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 27 Aug 2014 | Recall initiated by company | |
| 9 Oct 2014 | Classified by FDA | +43 days |
| 15 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.
Where it was distributed
Worldwide Distribution: US (Nationwide) including states of: AR, CA, CO, CT, IL, MA, NC, OH, PA, TN, TX, UT, VA, WA, WI; and Internationally to: AUSTRALIA, CHILE, UK, INDIA, IRELAND, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, and SAUDI ARABIA.
Nationwide ArkansasCaliforniaColoradoConnecticutIllinoisMassachusettsNorth CarolinaOhioPennsylvaniaTennesseeTexasUtahVirginiaWashingtonWisconsin
Questions about this recall
Is Charnley PN Retract & Handle recalled?
Yes. DePuy Orthopaedics recalled Charnley PN Retract & Handle on 27 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-0061-2015.
Why was it recalled?
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
Which lots are affected?
Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157
Where was it sold?
Worldwide Distribution: US (Nationwide) including states of: AR, CA, CO, CT, IL, MA, NC, OH, PA, TN, TX, UT, VA, WA, WI; and Internationally to: AUSTRALIA, CHILE, UK, INDIA, IRELAND, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, and SAUDI ARABIA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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