CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
Affixus Hip Fracture Nail, LH 130 DEG recalled by Zimmer Biomet
Zimmer Biomet is recalling Affixus Hip Fracture Nail, LH 130 DEG, distributed nationwide in the US. The recall was initiated on 7 Aug 2017 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-0442-2018
- FDA event ID
- 78763
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Aug 2017
- FDA classified
- 29 Jan 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 7 Aug 2017 | Recall initiated by company | |
| 29 Jan 2018 | Classified by FDA | +175 days |
| 7 Feb 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Product as listed by the FDA
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
Where it was distributed
US nationwide distribution. Also Portugal and the Netherlands.
Questions about this recall
Is Affixus Hip Fracture Nail, LH 130 DEG recalled?
Yes. Zimmer Biomet recalled Affixus Hip Fracture Nail, LH 130 DEG on 7 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0442-2018.
Why was it recalled?
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Which lots are affected?
Item No. 814609300; Lot No. (Exp. Date) UDI: 595480 (05/28/2027) UDI (01)00887868039676 (17)270528 (10)595480; 788380 (06/15/2027) UDI (01)00887868039676 (17)270615 (10)788380; 973000 (07/10/2027) UDI (01)00887868039676 (17)270710 (10)973000
Where was it sold?
US nationwide distribution. Also Portugal and the Netherlands.
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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|---|---|---|---|---|---|
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