CLASS II Device recall · Reported 1 Apr 2015 · FDA Enforcement Report
Variable Angle Locking Peg, D x L recalled by Flower Orthopedics
Flower Orthopedics is recalling Variable Angle Locking Peg, D x L, distributed in 9 states. The recall was initiated on 16 Feb 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-1314-2015
- FDA event ID
- 70578
- Recalling firm
- Flower Orthopedics, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Feb 2015
- FDA classified
- 24 Mar 2015
- Reported
- 1 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 16 Feb 2015 | Recall initiated by company | |
| 24 Mar 2015 | Classified by FDA | +36 days |
| 1 Apr 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
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
Product as listed by the FDA
Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
Where it was distributed
Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
CaliforniaFloridaIllinoisKentuckyNew YorkOklahomaPennsylvaniaTexasVirginia
Questions about this recall
Is Variable Angle Locking Peg, D x L recalled?
Yes. Flower Orthopedics recalled Variable Angle Locking Peg, D x L on 16 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-1314-2015.
Why was it recalled?
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
Which lots are affected?
All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
Where was it sold?
Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
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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