CLASS II Device recall · Reported 4 Nov 2015 · FDA Enforcement Report
Locking Screw Slf-tpng with T8 Stardrive Recess The Synthes recalled
Synthes (USA) Products is recalling Locking Screw Slf-tpng with T8 Stardrive Recess The Synthes modular Mini Fragment LCP, distributed in Tennessee. The recall was initiated on 6 Oct 2015 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-0167-2016
- FDA event ID
- 72345
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2015
- FDA classified
- 27 Oct 2015
- Reported
- 4 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 6 Oct 2015 | Recall initiated by company | |
| 27 Oct 2015 | Classified by FDA | +21 days |
| 4 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
Product as listed by the FDA
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
Where it was distributed
US Distribution to the state of : TN
Questions about this recall
Why was it recalled?
Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
Which lots are affected?
Part Number 202.212 Lot Number 3420620
Where was it sold?
US Distribution to the state of : TN
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 26 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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