Persona Partial Knee spacer block instruments — Class II medical device recall Z-1238-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-04-04, distributed nationwide. Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
| Recall number | Z-1238-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-11-29 |
| Classified | 2018-03-27 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, NL |
| Quantity | 1,023 |
| Lot numbers | 63767442, 63767443, 63769804, 63769805, 63769806, 63807190, 63813674 |
| Model numbers | 42-5399-035-08, 42-5399-035-09, 42-5399-035-10, 42-5399-035-12, 42-5399-035-14, 42-5399-035-14A, 63767442, 63767443, 63807190, 63813674 |
Product
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.
Reason for recall
Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1238-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.