CLASS II Device recall · Reported 10 Apr 2019 · FDA Enforcement Report
Biomet RingLoc Hip System Self-Tapping Bone Screw recalled
Zimmer Biomet is recalling Biomet RingLoc Hip System Self-Tapping Bone Screw 5mmx30mm-Low Profile Titanium, distributed nationwide in the US. The recall was initiated on 1 Mar 2019 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-1087-2019
- FDA event ID
- 82332
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2019
- FDA classified
- 4 Apr 2019
- Reported
- 10 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 1 Mar 2019 | Recall initiated by company | |
| 4 Apr 2019 | Classified by FDA | +34 days |
| 10 Apr 2019 | 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
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
Where it was distributed
Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
Questions about this recall
Is Biomet RingLoc Hip System Self-Tapping Bone Screw 5mmx30mm-Low Profile Titanium recalled?
Yes. Zimmer Biomet recalled Biomet RingLoc Hip System Self-Tapping Bone Screw 5mmx30mm-Low Profile Titanium on 1 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1087-2019.
Why was it recalled?
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Which lots are affected?
Lot Numbers/UDI Number 859960 (01) 00880304008700 (17) 280809 (10) 859960 859980 (01) 00880304008700 (17) 280805 (10) 859980 860120 (01) 00880304008700 (17) 280806 (10) 860120 860310 (01) 00880304008700 (17) 280823 (10) 860310 860580 (01) 00880304008700 (17) 280807 (10) 860580
Where was it sold?
Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
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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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |