Z-1273-2020Class II

TwinFix Ti 2.8 mm HS Suture Anchor -

Name: Z-1273-2020 TwinFix Ti 2.8 mm HS Suture Anchor -
Creator: Smith & Nephew, Inc.
Published: 2019-12-30
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2019-12-30 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone on 2019-12-30. FDA classified it as Class II and gives the reason as "Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1273-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-30
Posted: 2020-02-19
Terminated: 2021-05-11
Recalling firm: Smith & Nephew, Inc.
Product: TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Smith Nephew "Urgent Medical Device Recall Notice R-2019-22" letter dated December 30, 2019. Customers were advised to: 1.Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to [email protected] or fax to 901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected].
Quantity in commerce: 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units
Distribution: Worldwide distribution US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG.
Product codes and lots: Batch numbers: 2010547, 2025137, 2036695, 50763859, & 50773071. Part Number 72200796. UDI 10600147.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1273-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1273-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19

Product code MBI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)