Z-1019-2018Class II
CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Zimmer GmbH / initiated 2017-11-29 / Terminated / root cause: packaging
Zimmer Biomet, Inc. began a recall of CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented on . FDA classified it as Class II and gives the reason as "The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1019-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
- Product code
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Reason for recall
- The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag. A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additi
- Quantity in commerce
- 13,227 in total
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
- Product codes and lots
- Item Number: 00-8114-002-00 Lot Numbers: 62326105 61779347 62327662 62240744 62327663 62240745 62330760 62250379 62333960 62256011 62340054 62264280 62344682 62268572 62370963 62273048 62370965 62273049 62370966 62275085 62298278 62276441 62370975 62277490 62298279 62370968 62303495 62370969 62317907 62278684 62320168 62284463 62320169 62370971 62370976 62370972 62370978 62291922 62370979 62370973 62370990 62326104
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1014-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1015-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1016-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1017-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1018-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1019-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1020-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1021-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1022-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1023-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1024-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1025-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1026-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1027-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1028-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1029-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1030-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1031-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1032-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1033-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1034-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1035-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1036-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1037-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1038-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1039-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1040-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1041-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1042-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1043-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1044-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1045-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1046-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1047-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1048-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1049-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1050-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1051-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1052-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1053-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1054-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1055-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1056-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1057-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1058-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1059-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1060-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1061-2018 | Class II | Terminated | Voluntary: Firm initiated |
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