DEPUY (IRELAND): Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number

Hazard

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Details from the source

Reason for recall: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Distribution: Distribution to MN, NC, TX. Quantity: 160 units Lot/code info: 1. Part Number: 151730410. GTIN: 10603295529811. Lot Number: 1007709. 2. Part Number: 151730412. GTIN: 10603295529828. Lot Number: 1007710. 3. Part Number: 151730414. GTIN: 10603295529835. Lot Number: 1005246. 4. Part Number: 151730416. GTIN: 10603295529842. Lot Numbers: 1005247, AF1007712. 5. Part Number: 151730418. GTIN: 10603295529859. Lot Number: 1005248. 6. Part Number: 151730420. GTIN: 10603295529866. Lot Number: AF1008744. 7. Part Number: 151730422. GTIN: 10603295529873. Lot Number: 1007308, AF1007715. 8. Part Number: 151730424. GTIN: 10603295529880. Lot Number: 1005251. 9. Part Number: 151730426. GTIN: 10603295529897. Lot Number: 1007309, AF1009254. 10. Part Number: 151730408. GTIN: 10603295529903. Lot Number: 1005243. 11. Part Number: 151730510. GTIN: 10603295529910. Lot Number: 1008482. 12. Part Number: 151730512. GTIN: 10603295529927. Lot Number: AF1008370. 13. Part Number: 151730514. GTIN: 10603295529934. Lot Number: AF1008371. 14. Part Number: 151730516. GTIN: 10603295529941. Lot Number: AF1008372. 15. Part Number: 151730518. GTIN: 10603295529958. Lot Number: 1007067. 16. Part Number: 151730520. GTIN: 10603295529965. Lot Number: 1005343, 1008374. 17. Part Number: 151730522. GTIN: 10603295529972. Lot Number: 1005259. 18. Part Number: 151730524. GTIN: 10603295529989. Lot Number: 1008376. 19. Part Number: 151730526. GTIN: 10603295529996. Lot Number: 1005261, AF1008658. 20. Part Number: 151730508. GTIN: 10603295530008. Lot Number: 1005253. 21. Part Number: 151730710.

UPC codes

10603295529811, 10603295529828, 10603295529835, 10603295529842, 10603295529859, 10603295529866, 10603295529873, 10603295529880, 10603295529897, 10603295529903, 10603295529910, 10603295529927, 10603295529934, 10603295529941, 10603295529958, 10603295529965, 10603295529972, 10603295529989, 10603295529996, 10603295530008, 10603295530015, 10603295530022, 10603295530039, 10603295530046, 10603295530053, 10603295530060, 10603295530077, 10603295530084, 10603295530091, 10603295530107, 10603295544289, 10603295544296, 10603295544203, 10603295544210, 10603295544227, 10603295544234, 10603295544241, 10603295544272, 10603295544258, 10603295544265

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.